Summary

Agreement on Mutual Recognition Between EU Community and US FDA

Author:

Monitoring and Reporting Work Group

The US FDA and the EU announced that they have completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will now be able to utilize each other’s GMP inspections of pharmaceutical manufacturing facilities. The amended agreement ‎represents the culmination of nearly three years of U.S. FDA and EU cooperation as part of the Mutual Reliance Initiative and will allow the FDA and EU drug inspectors to rely upon information from API and drug inspections conducted within each other’s borders with the opportunity to accept inspections in 3rd countries too. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources around the world where there may be greater risk. The agreement also covers pre-approval and for-cause inspections, allowing US and EU authorities to request them and, if declined, to conduct them themselves, with the host authority joining. In addition, under Article 9 of the agreement, import testing can be waived as long as release testing is performed in the US and accompanied by a batch certificate.

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